• urupapuro_banner

GMP FARMaCoutical Icyumba Cyicyumba cya Hvac Guhitamo no Gushushanya

Icyumba gisukuye
GMP Icyumba gisukuye

Mu mitako ya GMP Icyumba cyiza cya farumasioutical, sisitemu ya HVAC niyo yibanze. Birashobora kuvugwa ko niba ibyuma byibidukikije byicyumba gisukuye bishobora kubahiriza ibisabwa ahanini biterwa na sisitemu ya HVAC. Sisitemu yo gushyushya hamwe na sisitemu yo guhumeka (HVAC) yitwa kandi uburyo bwo gukusanya ikirere muri farumasi gaze. Sisitemu ya HVAC itunganya cyane cyane icyumba cyinjiramo kandi igenzura ubushyuhe bwikirere, ubushuhe, guhagarika ibidukikije, itandukaniro ryibidukikije hamwe nibipimo bitanga imiti no kwirinda kubaho kwa farusi nambukiranya ikirere -Kwitabira mugihe utanga ibidukikije byiza kubatwara. Byongeye kandi, uburyo bworoshye bwa farumasi bwicyumba cya farumasi burashobora kandi kugabanya no kubuza ingaruka mbi ziterwa nibiyobyabwenge mugihe cyo kubyara, no kurinda ibidukikije bidukikije.

Muri rusange igishushanyo mbonera cya sisitemu yo kwezwa

Muri rusange igice cyo gusukura ikirere hamwe nibigizemo ibice bigomba gukorerwa ukurikije ibidukikije. Igice gikubiyemo ahanini ibice nko gushyushya, gukonjesha, ubushuhe, dehumipidimedictific, no kuzengurura. Ibindi bice birimo abafana bihumeka, garuka abafana bo mu kirere, sisitemu yo kugarura ingufu z'ubushyuhe, n'ibindi ntihagomba kubaho mu buryo bw'imbere muri gahunda ya HVAC, kandi icyuho kigomba kuba gito gishoboka kugirango wirinde kwirundara. Sisitemu ya HVAC igomba kuba yoroshye gusukura no kwihanganira ifumbire no kwanduza.

1. Ubwoko bwa sisitemu ya Hvac

Gahunda yo kwezwa ikirere irashobora kugabanywamo sisitemu yo gupima ikirere na sisitemu yo gukuraho ikirere. Sisitemu yo guhumeka ikirere yohereje umwuka wo hanze ushobora kubahiriza ibisabwa mucyumba, hanyuma usohoke umwuka. Sisitemu ikoresha hanze yumwuka wose. Sisitemu yo gukuraho ikirere, ni ukuvuga icyumba cyo mu kirere gisukuye kivanze nigice cyo hanze yinzego nshya kandi igice cyumwuka usubiza mucyumba cyiza. Kubera ko uburyo bwo gukemura ikirere bufite akamaro ko gushora imari nkeya no kugura ibintu bike, uburyo bwo guhuza ikirere bugomba gukoreshwa muburyo bushoboka bushoboka mugushushanya ikirere. Umwuka mubice bimwe byihariye byo kubyara ntibishobora gukoreshwa, nkicyumba cyiza (agace) gutangwa mugihe cyo kubyara, no kwanduza kwambuka ntibishobora kwirindwa iyo ikirere cyo mu nzu cyafashwe; Ibicuruzwa bya kama bikoreshwa mu musaruro, no kwirundanya gaze birashobora gutera ibisasu cyangwa umuriro n'ibintu biteje akaga; Ahantu hashyizweho na Pathogen; Ahantu ha farumatiya ya farumasi; Inzira z'umusaruro zitanga byinshi mubintu byangiza, impumuro cyangwa imyuka ihindagurika mugihe cyimikorere.

Agace ka farumasi gashobora kugabanywa mubice byinshi hamwe ninzego zitandukanye. Ahantu hasukuye hagomba kuba bifite ibikoresho byigenga byigenga. Buri sisitemu yo guhumeka itandukanijwe kumubiri kugirango irinde kwanduza ibikomokaho. Ibice byinshi byigenga birashobora kandi gukoreshwa ahantu hatandukanye cyangwa uduce dutandukanye twihimbanya binyuze muri sisitemu yo guhuriza hamwe no gukumira imisaruro . igomba kuba ifite ibikoresho bitandukanye byo gutunganya umwuka. Kubintu byo kumusaruro bifite imyanya itandukanye cyangwa inshuro nyinshi kandi bitandukanye mubushyuhe nubushyuhe bwo kugenzura ubushyuhe, sisitemu yo kugenzura ikirere nayo igomba gushyirwaho ukundi.

2. Imikorere n'ingamba

(1). Gushyushya no gukonjesha

Umusaruro utanga umusaruro ugomba guhuzwa nibisabwa. Iyo nta bisabwa byihariye kumusaruro wa farumasi, ubushyuhe bwibanze C na Stand D Ibyumba bisukuye birashobora kugenzurwa kuri 18 ~ 26 ° C, Ubushyuhe bwa C, nubushyuhe bwa B, ibyumba bisukuye birashobora kugenzurwa kuri 20 ~ 24 ° C. Muri sisitemu yo guhumeka neza, amabati ashyushye kandi akonje hamwe nubushyuhe bwamashanyarazi, ibitutsi bya tuburland. Iyo ingano yumwuka ari nini nini, ushimangira umwuka mwiza ugomba gufatwa nkubuza abapolisi batoroka. Cyangwa gukoresha bidashidikanywaho kandi bikonje, nkamazi ashyushye kandi akonje, yujuje ibisabwa, ibisabwa kugirango bishyure umwuka ushushe cyangwa ubukonje, ubuziranenge bwibicuruzwa, ubukungu, nibindi bihitamo bishingiye kubiciro nibindi bisabwa.

(2). Ubushuhe no Deshumidipiteri

Ubworoherane bugereranije bwicyumba gisukuye bugomba guhuzwa nibisabwa numusaruro wa farumasi, kandi hagomba guhumurizwa na farumasi kandi ihumure rikwiye. Iyo nta bisabwa byihariye kumusaruro wa farumasi, ubushuhe bugereranije D na Stand D Uturere d hagenzurwa na 45% kugeza 65%, hamwe nubushuhe bwa FISITEKEST bigenzurwa na 45% kugeza 60% kugeza 60% .

Ibicuruzwa bya poweli yifu cyangwa imyiteguro ikomeye bisaba uburyohe bwo kugabanya imisaruro mike. Dehumishings hamwe na cost-coolers irashobora gufatwa nkibikurura. Kubera ishoramari ryinshi nibiciro bikora, ubushyuhe bwa DEW busanzwe bugomba kuba munsi ya 5 ° C. Ibikorwa bitanga umusaruro hamwe nubushyuhe bwinshi birashobora kugumanwa no gukoresha ifarashi, ibikoresho byiza byateguwe kuva mumazi meza, cyangwa binyuze mu guhuriza hamwe. Iyo icyumba gisukuye gifite ibisabwa ugereranije, umwuka wo hanze mu mpeshyi ugomba gukonjeshwa na cooler hanyuma ukarangirwa no gushyuha kugirango uhindure ubushuhe bugereranijwe. Niba amashanyarazi yo mu mashanyarazi agomba kugenzurwa, ubuhubuke bugomba gufatwa nk'iza rikonje cyangwa ryumye.

(3). Akayunguruzo

Umubare wumukungugu na mikorobe mu kirere nziza no gusubiza umwuka mwiza birashobora kugabanuka kugeza kuri sisitemu ya HVAC, wemerera umusaruro kugirango uhuze ibisabwa mu isuku. Muri sisitemu yo kwezwa mu kirere, ibikaba byo mu kirere bigabanijwemo ibyiciro bitatu: kubanza, kurwara hagati, guhuzagurika no kurwara Hepa. Buri cyiciro ikoresha muyunguruzi yibikoresho bitandukanye. Prefilter nicyo gito kandi yashyizwe mugitangira igice cyo gukemura ikirere. Irashobora gufata ibice binini mukirere (ubunini bwumuyaga hejuru ya microns 3). Filtrateur filtration iherereye iheruka kumanuka kwiyamamaza mbere yo kuyungurura kandi yashyizwe hagati yishami rikoreshwa ryindege aho binjira mu kirere. Ikoreshwa mugufata ibice bito (ingano yinshi hejuru ya 0.3). Filtration yanyuma iherereye mu gice cyo gusohora ikirere, gishobora kuguma isuku no kwagura ubuzima bwa serivisi.

Iyo urwego rwisuku rwisuku ruri hejuru, umuyunguruzo wa Hepa washizwemo hasi yinda ya nyuma nkigikoresho cyuzuye. Igikoresho cyo kuyungurura ibicuruzwa biherereye kumpera yindege yindege kandi yashyizwe kumurongo cyangwa kurukuta rwicyumba. Irashobora kwemeza itangwa ryumwukasumbanya kandi ikoreshwa mugutandukanya cyangwa kohereza ibice byashyizwe mucyumba gisukuye, nkicyiciro cya B Icyumba Cyasukuye cyangwa Icyumba gisukuye.

(4). Kugenzura

Icyumba gisukuye cyane kigumana igitutu cyiza, mugihe Icyumba kiganisha kuri iki cyumba gisukuye kibungabunge imikazo yo hepfo kandi yo hepfo, kugeza kurwego rwa zeru kumwanya utagenzuwe (inyubako rusange). Itandukaniro ry'umuvuduko hagati y'ibice bisukuye hamwe n'ahantu hatanduye no hagati y'ibice bisukuye kandi bifite aho binyuranye bitagomba no gukomezwa hagati y'ibice bitandukanye by'imikorere (ibyumba byo gukora). Umuvuduko mwiza wakomereje mucyumba gisukuye birashobora kugerwaho na extroud Exme ikaba nini kuruta imiti ishimishije. Guhindura amajwi yo gutanga ikirere birashobora guhindura itandukaniro ryikibazo hagati ya buri cyumba. Umusaruro udasanzwe w'ibiyobyabwenge, nk'ibiyobyabwenge bya penisiline, ahantu hakora itanga umukungugu mwinshi ugomba gukomeza igitutu kibi ugereranije.

Icyumba gisukuye cya farumasi
Igice cyo gukemura ikirere

Igihe cyohereza: Ukuboza-19-2023